Many men, women and children undergo reconstructive surgery every year. This is oftentimes done to improve or restore their appearance by replacing a body part which has been lost or removed or to cover an undesirable scar or defect. Common forms of reconstructive surgery involve recreation of the breast mound after mastectomy, removal of surface abnormalities such as scars or vascular malformations, removal of tumors and reconstruction of the defect or restoration of normal anatomy following correction of a congenital defect.
For example, women (and occasionally men) must sometimes undergo mastectomy which removes all or portions of their breast with or without the nipple and areolar complex. Following this surgical procedure, many of these patients elect to undergo reconstructive surgery to recreate their breast mound either utilizing an implantable prosthetic device or with their own tissue. Although not restoring function, these procedures do improve their physical appearance and restore balance to the chest wall. Other patients who have been in accidents sustaining severe scarring or have lost body parts, individuals who have been in fires and sustained thermal injury or patients who have been born with congenital abnormalities may also require or elect to have reconstructive surgery to restore their normal appearance and function. Currently there are also nonsurgical options for reconstruction such as prosthetic breasts which are worn on top of the chest wall to restore forward projection in a bra. Rubbed on surface cosmetics have been used to cover scars. Professional tattooing is also currently being used to cover scars and other surface defects, as well as simulate body parts which are missing (eyebrows). Unfortunately, these nonsurgical options are not perfect and oftentimes have contraindications which prevent the patient from utilizing them.
Although there are a number of implantable prostheses and tissue types which simulate the shape and texture of a natural breast, none of them create a natural-appearing breast mound because they all lack a nipple and areolar complex. A patient, who for a number of reasons cannot have immediate reconstruction, has a significant chest wall defect not only because of a lack of breast mound, but because the nipple and areolar complex is absent, as well. The existing implantable breast prostheses and the tissue reconstruction options fall short in recreating the nipple and areolar complex and lack a normal nipple prominence shape and color. This makes the reconstruction inadequate and a third stage, i.e., nipple and areolar reconstruction, is considered the last phase of breast reconstruction. Oftentimes, however, patients for one reason or another are unable to undergo this final stage for months and continue to lack the shape and color of the nipple and areolar complex. The implantable prosthesis disclosed in U.S. Pat. No. 4,778,465 (Wilkins) tries to recreate the nipple prominence, but, unfortunately, the skin that overlies this implant is normal chest wall skin and scar only without color or texture of the normal nipple and areolar complex.
Three dimensional prosthetic nipple and areolar complexes, which are applied to the outside of the chest wall skin after reconstruction of the breast mound, do attempt to approximate a natural nipple shape, texture and color (U.S. Pat. No. 5,171,321--Davis). These prosthetic devices attach to the skin of the chest wall via adhesive or suction. However, since their inner surface is concave in order to attach and stay firmly adherent to the body, a close approximation to the breast mound or at least the chest skin must be present in order for it to work. Very often a good surface does not exist and these non-customized, limited-shaped, prosthetic nipples do not and will not fit on the mastectomized chest wall well. Patients become discouraged with their lack of fit and are always having to reapply them. Also, because these particular prosthetic nipple and areolar devices are not customized, the patient cannot adjust for individual size or shape and there is no clear method for matching these devices to the skin tone of the patient. Because there is constant motion of the breast mound and chest wall dislodgement of these prostheses occurs constantly even if attempted to be held on by adhesion or suction. Therefore, they always look unnatural and the patient is reluctant to wear them.
Another problem with the existing methods of nipple and areolar reconstruction (permanent tattooing, surgical creation of a nipple and areolar complex, glued on devices) is that often they cannot be utilized until a significant amount of time has passed after the initial breast mound reconstruction. This is due to the constraints of healing, chemotherapy, radiation and recovery time for the patient. The reconstructive processes oftentimes take many months. There must be enough time allowed for surgical incision healing, resolution of swelling, the expansion process, any revisions that might need to be provided and the patient's systemic illnesses possibly brought on by chemotherapy and radiation. All of these considerations require time and the patient while waiting for treatment in time to progress wants to look as natural as possible to allow them to get on with their lives. The current methods for aesthetic improvements do not enable these women to achieve this goal.
Devices for customizing the color of a prosthetic device have been disclosed, such as U.S. Pat. No. 4,735,754 (Buckner) and No. 5,727,567 (Karnaby, et al). These methods basically involve a labor-intensive process of painting the desired image onto the prosthetic device or layering latex in varying colors on the prosthetic device in order to produce a more realistic skin tone appearance. U.S. Pat. No. 5,798,062 (Thielbar) discloses a method of creating a breast/nipple prosthesis that is worn on the outside of the body and is color matched. However, these methods disclosed in the prior methods are deficient in that the colors must be applied to the prosthetic device itself and may not be applied directly to the skin thereby allowing the same displacement complaints. The prior methods are also deficient in that only stock colors are provided and the user must try herself to mix them in order to achieve the desired pigmentation to match her skin tones. Furthermore, matching is done visually, which is not as accurate as the formation of a computerized digital image followed up by an accurate printing method which produces a more exact reproduction of the skin tone size and shape.
Permanent tattooing in order to replace a missing body part or to cover a portion of the body is another option existing to improve or alter a patient's appearance. However, this method has many undesirable consequences. It is painful, there is a real risk of contracting HIV or hepatitis and a permanent tattoo cannot be altered to match the changing skin tones of an aging patient. Furthermore, the use of a permanent tattoo is undesirable in the case of a lost eyebrow because it cannot be removed when the natural eyebrow grows back. The present invention eliminates all of these concerns.